Guide
FDA import refusal: what happens next
Updated 7 min read8 primary sources
When FDA refuses an imported shipment, it issues a Notice of Refusal of Admission, and the goods must be exported or destroyed under CBP supervision within 90 days of the notice; goods not redelivered to CBP can lead to a claim for liquidated damages under the entry bond. A refusal is FDA's final decision on that shipment, and FDA does not reconsider it unless it was issued in error.
Key facts
- Notice
- Notice of Refusal of Admission, sent to the importer of record and CBP
- Options
- Export or destroy, under CBP and FDA supervision
- Deadline
- 90 days from the date of the refusal notice (FD&C Act 801(a))
- Extensions
- FDA cannot extend the 90 days; ask the local CBP office
- Appeal
- None, unless FDA issued the refusal in error
What is an FDA import refusal?
FDA defines a refusal as its final decision that a detained shipment is in violation of FDA laws and regulations. A refusal always follows a detention: FDA first detains the goods and gives the owner or consignee a chance to respond, then either releases them or refuses them.
FDA's Import Refusals page lists typical reasons a detained shipment ends up refused: no response by the deadline on the Notice of Detention and Hearing, evidence that did not overcome the appearance of a violation (for example a private laboratory report FDA found invalid), a reconditioning proposal that was denied, or two reconditioning attempts that both failed.
What are the steps from detention to refusal?
- 01
Detention
FDA issues a Notice of FDA Action marked Detained, also called the Notice of Detention and Hearing, which lists the charges and a respond-by date.
- 02
Hearing and testimony
The owner, consignee or importer of record may submit oral or written testimony, such as private laboratory results, to show the goods are admissible (21 CFR 1.94).
- 03
Optional reconditioning
The importer of record may apply on Form FDA 766 to relabel or recondition the goods to bring them into compliance.
- 04
Decision
FDA either releases the goods or issues a Notice of Refusal of Admission stating the same charges as the detention notice.
- 05
Export or destruction
The refused goods must be exported or destroyed under CBP supervision within 90 days of the refusal notice.
- 06
Public record
Final refusals are published in FDA's import refusal data with the firm, product code and refusal charge codes.
How long do you have after an FDA detention or refusal?
| Step | Time limit | Source |
|---|---|---|
| Respond to the detention notice | The respond-by date on the notice: RPM allows 10 business days; the notice generally states 20 calendar days | FDA Detention & Hearing page; RPM 9-1-5 |
| Ask for more time to respond | Before the respond-by date, with a reasonable basis | FDA Detention & Hearing page |
| Complete approved reconditioning | Within the time FDA sets in its approval | FDA Reconditioning page; 21 CFR 1.96 |
| Export or destroy refused goods | 90 days from the date of the refusal notice, or additional time CBP permits | FD&C Act 801(a); RPM 9-1-5 |
“The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations”
What happens if refused goods are not exported or destroyed in 90 days?
When FDA refuses goods, CBP is notified and requests that the importer redeliver them to a CBP-approved location at a port of entry. FDA's Import Refusals page says that if the importer fails to do so, CBP may assess liquidated damages against the bond. The refusal notice itself warns that distributing refused products may lead to seizure, injunction or criminal prosecution.
FDA has no authority to extend the 90 days. Questions about more time go to the local CBP office.
Can you appeal an FDA import refusal?
Not in the usual sense. FDA's Import Refusals page says a refusal is a final decision, and that unless it was issued in error, FDA does not consider requests to rescind it. The time to make your case is during the detention, before the respond-by date.
Can a detained shipment be fixed instead of refused?
Sometimes. Under section 801(b) and 21 CFR 1.95, the importer of record can apply on Form FDA 766 to relabel or recondition goods detained under section 801(a)(3), with a timeframe and a detailed plan. FDA verifies the work at the importer's expense. FDA's Reconditioning page says a second application is normally approved only with meaningful changes, and a third attempt will generally not be granted.
If only part of a reconditioned shipment passes, the rejected portion is refused and must be exported or destroyed.
Is an FDA import refusal public?
Yes. The FDA Data Dashboard publishes import refusal data for shipments refused on or after 10/01/2016, updated weekly and limited to final actions. Each record includes the firm name and FEI number, country, product code, refusal date and the refusal charge codes; older records are in FDA's legacy Import Refusal Report.
Charge codes such as SALMONELLA or NO PROCESS are explained in FDA refusal charge codes explained. SupplierRadar shows each supplier's refusals on its public page and aggregates them by country, for example refusals from Vietnam.
What does a refusal mean for your FSVP?
A refusal of a supplier's food is information about that supplier's food safety history, which 21 CFR 1.505(a)(1)(iii)(C) requires you to consider, including results from testing foods for hazards. When it is new to you, it can call for a prompt reevaluation under 1.505(c)(1), and if it shows the food is adulterated, corrective action under 1.508. See When to reevaluate a foreign supplier under FSVP.
A single refusal does not by itself place a supplier on an import alert, but FDA's Regulatory Procedures Manual describes cases where one violative sample can support DWPE, such as a pesticide or aflatoxin violation or a low-acid canned food without a filed process. See Detention without physical examination.
Frequently asked questions
- How long do I have to export or destroy a shipment refused by FDA?
- Ninety days from the date of the Notice of Refusal of Admission, under section 801(a) of the FD&C Act, or any additional time CBP permits. FDA itself cannot extend the 90 days.
- Can I appeal an FDA import refusal?
- FDA says a refusal is a final decision and that it does not consider requests to rescind one unless it was issued in error. Evidence must be presented during the detention, before the respond-by date.
- What happens if I miss the respond-by date on an FDA detention notice?
- The compliance officer can issue a refusal of admission. You can request an extension, but only before the respond-by date and with a reasonable basis.
- Who receives the FDA refusal notice?
- FDA always issues the Notice of Refusal of Admission to the importer of record, the same party that received the detention notice, and notifies CBP. Local practice may also send copies to the broker and consignee.
- Does an FDA refusal put my supplier on an import alert?
- Not automatically. FDA can recommend detention without physical examination based on refusal history or, in some situations described in its Regulatory Procedures Manual, on one violative sample.
- Where can I see a supplier's FDA import refusals?
- On the FDA Data Dashboard, which covers shipments refused on or after 10/01/2016 and is updated weekly. SupplierRadar's supplier pages show the same refusals with their dates and charge codes.
Sources
Every legal and FDA-process claim above is cited to a primary source. Access dates show when each page was read.
- 01FDA: Import RefusalsFDA · accessed
- 02FDA: Detention & HearingFDA · accessed
- 03FDA: ReconditioningFDA · accessed
- 0421 U.S.C. 381, FD&C Act section 801 (Cornell LII)Cornell LII · accessed
- 0521 CFR 1.94 (eCFR)eCFR · accessed
- 06FDA Regulatory Procedures Manual, Chapter 9 (March 2024)FDA · accessed
- 07FDA Data Dashboard: Import RefusalsFDA · accessed
- 08FDA Data Dashboard API: Import Refusals field definitionsFDA · accessed
Related
Put it into practice
See a supplier's refusals before you order
Every supplier page on SupplierRadar lists its FDA import refusals since 2016 with dates, products and charge codes, linked to FDA's data. Watch a supplier and get an email when a new refusal is published.
SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.